A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

Who is eligible to participate?

Inclusion Criteria: - Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA) system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of the two systems. - Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX system with a > 70% stenosis in the system. - Medial sternotomy with cardiopulmonary bypass (CPB) during surgery. - Both saphenous vein graft length are adequate for planned intervention, vein outer diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm. - Agreement to post-procedure follow-up contact and testing (including follow-up coronary angiogram). Exclusion Criteria: - Concomitant non-CABG cardiac procedure. - Prior cardiac surgery (does not include percutaneous procedures). - Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure. - Age > 85 years. - Left ventricular ejection fraction ≤ 35%. - Creatinine > 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis. - STEMI within 7 days or total CK > 2 times the upper limit of normal prior to the CABG procedure. - Both enrolled grafts will feed non-viable myocardial territory. - Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled target coronary arteries. - Randomized Cohort: By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other. - Planned endarterectomy of the target coronary artery.

Last updated:

2/27/2014

NCT ID:

NCT01676376

IRB Number:

12-009450